Not yet recruitingNCT07879430ADAPT-DCBUpdated Oct 16, 2026

1-Month Versus 6-Month Dual Antiplatelet Therapy After Successful Drug-Coated Balloon-Only Percutaneous Coronary Intervention

An interventional study of 1-Month DAPT and 6-Month DAPT in Coronary Artery Disease (CAD), sponsored by Ulsan University Hospital. Not yet recruiting. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Ulsan University Hospital · Not applicable, Interventional, and Treatment

Updated Oct 16, 2026Newly registeredGo to Updates ↓

Phase: Not applicable
Study type: Interventional
Enrollment: 1,258
Allocation: Randomized
Ages: 19 Years and older
Sex: All

Study summary

This study will compare the clinical outcomes of a 1-month dual antiplatelet therapy (DAPT) strategy with a standard 6-month DAPT strategy in patients undergoing successful drug-coated balloon-only percutaneous coronary intervention (DCB-only PCI). The study will evaluate net adverse clinical events (NACE) at 12 months to assess whether short-term 1-month DAPT is non-inferior to 6-month DAPT. The study is a prospective, randomized, open-label, blinded-endpoint, multicenter trial.

Read the detailed description

This study evaluates whether a short-term 1-month dual antiplatelet therapy (DAPT) strategy is non-inferior to the standard 6-month DAPT strategy in patients who have undergone successful drug-coated balloon-only percutaneous coronary intervention (DCB-only PCI).

Patients aged 19 years or older presenting with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS) who achieve successful treatment with drug-coated balloons without any permanent stent or scaffold implantation will be enrolled. Eligible participants will be randomly assigned in a 1:1 ratio to either 1-month DAPT followed by single antiplatelet therapy (SAPT) or standard 6-month DAPT followed by SAPT. The primary endpoint is the time to first net adverse clinical events (NACE) from randomization through 12 months, defined as a composite of all-cause death, non-fatal myocardial infarction, clinically driven target vessel revascularization, or Bleeding Academic Research Consortium (BARC) type 2-5 bleeding.

Secondary outcomes include individual components of NACE, target lesion failure (TLF), total bleeding events according to BARC criteria, and clinical outcomes evaluated at a pre-specified 30-day landmark analysis. Clinical events will be adjudicated by an independent Clinical Events Committee.

This is a prospective, multicenter, randomized, open-label, blinded-endpoint (PROBE), parallel-group, non-inferiority study. If clinically indicated, antiplatelet therapy may be modified or adjusted according to the investigator's clinical judgment with proper documentation.

Conditions studied

Coronary Artery Disease (CAD)

Browse trials for

Coronary Artery Disease 5,676

Keywords

Dual Antiplatelet Therapy
Drug-Coated Balloon
Percutaneous Coronary Intervention
Coronary Artery Disease
Short-Term DAPT

In context

Coronary Artery Disease

5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.

This study's planned enrollment of 1,258 is above the median of 123 across 3,481 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Ulsan University Hospital is the lead sponsor of 27 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

[Inclusion Criteria]

Age ≥19 years.
Written informed consent obtained before randomization and before any study-specific procedures. The conditions allowing consent before or after PCI follow the footnote of the Schedule of Assessments.
Presenting with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS, including unstable angina, non-ST-segment elevation myocardial infarction, or ST-segment elevation myocardial infarction), and clinically stable after PCI.
Has an indication for coronary PCI based on symptoms, objective ischemia, ACS clinical presentation, coronary physiology, or angiographic findings per routine practice.
All treated lesions were treated with the Pantera Lux DCB only and Successful DCB-only PCI in all treated lesions, with visually estimated residual diameter stenosis ≤30%, TIMI grade 3 flow, and no flow-limiting dissection, persistent ischemia, or unresolved major procedural complications.
No coronary stent or scaffold was implanted during the index procedure.
Able and willing to comply with the assigned antiplatelet regimen and scheduled follow-up, and judged by the investigator to be clinically acceptable for both the 1-month and 6-month DAPT strategies using the P2Y12 inhibitor selected by the investigator.

[Exclusion Criteria]

Unable or unwilling to provide written informed consent.
Known contraindication, hypersensitivity, or clinically unacceptable intolerance to aspirin, any P2Y12 inhibitor permitted by the protocol, heparin, paclitaxel, DCB excipients, or iodinated contrast media that cannot be adequately controlled.
Active major bleeding at the time of randomization, or another condition that precludes DAPT.
Requires, or is expected to require, oral anticoagulation after randomization; or has a separate clinical indication, independent of study assignment, that necessitates DAPT beyond 1 month or makes it impossible to maintain 6-month DAPT, such that one of the two assigned strategies would be inappropriate.
Cardiogenic shock, persistent hemodynamic instability, or need for mechanical circulatory support at randomization.
Bailout or planned coronary stent/scaffold implantation during the index procedure.
Additional PCI (including DCB-only PCI) or CABG planned within the first 6 months after randomization.
Coronary stent implantation within 6 months before randomization.
History of definite or probable stent thrombosis.
In-stent restenosis or stent thrombosis as the study target lesion.
Prior coronary artery bypass grafting (CABG).
Life expectancy \<1 year due to comorbid conditions.
Currently participating in another interventional study that may interfere with treatment or endpoint ascertainment.
Pregnant or breastfeeding, or planning pregnancy during the assigned DAPT period.
Any other condition in which, in the investigator's judgment, study participation is unsafe or reliable follow-up is unlikely.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 1,258 participants (estimated)

Study arms

Experimental
1-Month DAPT Group
Patients receiving successful drug-coated balloon-only PCI will undergo dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor) for 1 month post-procedure, followed by single antiplatelet therapy (SAPT).
Drug: 1-Month DAPT
Active comparator
6-Month DAPT Group
Patients receiving successful drug-coated balloon-only PCI will undergo standard dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor) for 6 months post-procedure, followed by single antiplatelet therapy (SAPT).
Drug: 6-Month DAPT

Interventions

Drug1-Month DAPT
Patients receive dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor) for 1 month (30 days) following successful drug-coated balloon-only percutaneous coronary intervention (PCI). Aspirin is discontinued between Days 25 and 35, after which patients transition to single antiplatelet therapy (P2Y12 inhibitor monotherapy) through 12 months.
Drug6-Month DAPT
Patients receive dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor) for 6 months (180 days) following successful drug-coated balloon-only percutaneous coronary intervention (PCI). Aspirin is discontinued between Days 166 and 194, after which patients transition to single antiplatelet therapy (P2Y12 inhibitor monotherapy) through 12 months.

What researchers measure

Primary outcomes

NACE: at 12 Months
NACE is defined as a composite of all-cause death, non-fatal myocardial infarction (MI), clinically driven target vessel revascularization (TVR), or Bleeding Academic Research Consortium (BARC) type 2-5 bleeding.
Time frame: From randomization up to 12 months

Secondary outcomes

NACE: at 24 Months
Composite of all-cause death, non-fatal myocardial infarction (MI), clinically driven target vessel revascularization (TVR), or Bleeding Academic Research Consortium (BARC) type 2-5 bleeding.
Time frame: From randomization up to 24 months
Individual Components of NACE
Incidence of all-cause death, cardiac death, non-fatal MI (spontaneous or target-vessel MI), clinically driven TVR, and clinically driven target lesion revascularization (TLR).
Time frame: Up to 12 months and 24 months
Target Lesion Failure (TLF)
Composite of cardiac death, target vessel MI, or clinically driven TLR.
Time frame: Up to 12 months and 24 months
BARC Type 2-5 and Type 3-5 Bleeding
Bleeding events defined according to Bleeding Academic Research Consortium (BARC) criteria.
Time frame: Up to 12 months and 24 months
Stroke
Acute focal or global neurological deficit of vascular cause, classified as ischemic, hemorrhagic, or undetermined stroke.
Time frame: Up to 12 months and 24 months
Target Lesion Thrombosis and Acute Vessel Closure
Definite or probable thrombotic occlusion or acute vessel closure within the DCB-treated segment adjudicated by DCB ARC criteria.
Time frame: Up to 24 months
Medication Adherence
Rate of adherence to assigned antiplatelet therapy, temporary interruption, permanent discontinuation, and treatment crossover.
Time frame: 1, 6, 12, and 24 months
Ischemic composite endpoint
First occurrence of cardiovascular death, non-fatal myocardial infarction, or ischemic stroke.
Time frame: 12 months and 24 months after randomization

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

1 registry update since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2028, 24 months later.

Of 856 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's planned 24 months is below that.

Counting every sponsor, half of 1,033 studies reached it within 29 months; a quarter within 14 and three quarters within 49.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 11, 2026
First posted: Oct 16, 2026
StartEst.: Oct 19, 2026
Primary completionEst.: Oct 31, 2028
CompletionEst.: Oct 31, 2029
Last update: Oct 16, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

Registered

First appeared on the registry. No changes since

Oct 16, 2026

Show all 1 update

Oct 16, 2026
First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07879430
Lead sponsor: Ulsan University Hospital
Collaborators: KangWon National University Hospital, Korea University Guro Hospital, Hanyang University Seoul Hospital, Kosin University Gospel Hospital, Chonnam National University Hospital, Gyeongsang National University Changwon Hospital, Hallym University Medical Center, Daegu Catholic University Medical Center, Sinchon Severance Hospital, Yonsei University College of Medicine, Ulsan Medical Center, Korea University Ansan Hospital, Pusan National University Yangsan Hospital, Inje University
Responsible party: Eun-Seok Shin (Study Principal Investigator, Ulsan University Hospital) — Principal investigator
First posted: Oct 16, 2026
Start date: Oct 19, 2026 (estimated)
Primary completion: Oct 31, 2028 (estimated)
Completion: Oct 31, 2029 (estimated)
Last update: Oct 16, 2026

Study contacts

Eun-Seok Shin, Professor

Contact

sesim1989@gmail.com

82-52-250-5020

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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